510(k) K193295

Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor by Parcus Medical, LLC — Product Code MBI

K193295 is an FDA 510(k) premarket notification submitted by Parcus Medical, LLC for the device "Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor". The FDA issued a decision of Substantially Equivalent on Jan 23, 2020. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Parcus Medical, LLC has at least 10 other 510(k) clearances on record.